ProJect Pharmaceutics is excited to open newly expanded lab space, now home to our most recent acquisition: the Orbitrap Exploris 240 LC-MS – a cutting edge, high-resolution platform capturing complex molecular insights and delivering deeper analytical clarity for complex formulation challenges. Curious what next-level analytics can do for your project?
The multi-attribute method (MAM), a liquid chromatography-mass spectrometry (LC-MS)-based peptide mapping method, has started to gain increased interest and applications in the biopharmaceutical industry. MAM can, by applying only one method, provide targeted quantitation of multiple site-specific product quality attributes, as well as new peak detection (Yang et al., Mass spectrometry-based multi-attribute method in protein therapeutics product quality monitoring and quality control, MABS 2023, Vol. 15, No. 1, 2197668). These days, LC-MS is rapidly emerging as a preferred technology for Multiple-Attribute Analysis (MAA), especially for complex biologics. By consolidating into a single, information-rich run what previously required multiple chromatographic methods (RP, IEX, HIC, R-CE-SDS, etc.), LC-MS provides detailed molecular insights, enabling monitoring of critical quality attributes of complex therapeutic proteins. Several literatures (i.a. Rathore et al., The role of mass spectrometry in the characterization of biologic protein products, Expert Rev Proteomics, 2018, 15(5), 431-49) have divided the role of MS in the characterization of biologics into the following main areas: product identity testing, characterization, comparability assessment, adulteration analysis, demonstration of critical quality attribute consistency during product development, and in PK/PD studies. A trend today, a potential regulatory standard for quality control (QC) testing tomorrow? ProJect Pharmaceutics is already leading the way with next-generation technology on board!
ProJect Pharmaceutics is a CRO specialized in formulation and lyophilization process development for injectable drug products. Our newest team member, the Orbitrap Exploris 240 LC-MS (by Thermo Fisher), has moved into our expanded laboratory space, enabling next-level analytics for formulation and process development of injectable drug products, such as:
- mAb and ADC characterization
- Native DAR determination by SEC-MS
- Drug-load-distribution by PepMap
- Detection of degradation (fragments, side chain modifications, hydrolysis)
- Analysis of mAb glycosylation
- Impurity analysis (e.g. HCP)
Partner with us to unlock faster, deeper, and more precise analytical insights.